AbbVie submits regulatory applications to FDA and EMA for upadacitinib in atopic dermatitis

Approval is sought for treatment of adults (15 and 30mg daily) and adolescents (15mg daily) with moderate/severe atopic dermatitis; and supported by data from three pivotal Phase 3 studies demonstrating significant improvement in skin clearance and reduction in itch vs. placebo.

SPS commentary:

Currently upadacitinib is licensed for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs.

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